Catalog Number

-

Brand Name

StarDental Instrument Solutions

Version/Model Number

202397

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 07, 2019

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EKK

Product Code Name

Spreader, Pulp Canal Filling Material, Endodontic

Public Device Record Key

4d64ddc0-c2d1-4d20-a35e-03fe1fc1f4f7

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-